Clinical research has shown utility of electrical nerve stimulation for urinary incontinence and a broad group of urological disorders. This invention is directed to method and system for providing pulsed electrical stimulation adjunct therapy for urological disorders. These urological disorders include, urinary incontinence, overflow incontinence, stress incontinence, neuro-urological disorder, bladder inflammation, bladder pain and the like.
With reference to prior art, U.S. Pat. No. 5,562,717 (Tippey et al) teaches an external system comprising a portable electrical stimulator which can be coupled to one or more electrodes for applying electrical stimulation signals to a patient. The signal generator being responsive to the instruction storage or programming device.
U.S. Pat. No. 6,393,323 B1 (Sawan et al) teaches a selective stimulation system which is composed of an internal stimulator implanted in the patient and operated with an external hand-held controller. The system being used to prevent bladder hyeperreflexia combined with a voiding signal generator generating a voiding signal for voiding the bladder.
U.S. Pat. No. 6,505,074 B2 (Boveja et al) is directed to an implanted stimulus receiver coupled with an external stimulator for providing neuromodulation therapy. U.S. Pat. No. 6,449,512 B1 (Boveja) is directed to an implantable pulse generator for providing electrical stimulation therapy for urological disorders. The implanted pulse generator, though convenient, has the disadvantage that the internal battery will not last for a desired period of time, which can lead to repeated surgeries for generator replacement. The inductively coupled implanted stimulus receiver overcomes the disadvantage of implanted battery replacement, but patient convenience is an issue since a primary coil has to be kept in close proximity to an implanted secondary coil. It would be desirable to have the advantages of both an IPG system and an inductively coupled system. The system and method disclosed, provides an improved method and system for adjunct therapy by providing a system that has the benefits of both systems, and has additional synergistic benefits not possible in the prior art. In the system of this invention, the patient can choose when to use an external inductively coupled system to conserve the battery life of the implanted module and receive higher levels of therapy.
The current application discloses an implanted medical device capable of being used as a programmable implanted pulse generator (IPG), or as a stimulus-receiver, for an inductively coupled system with power being supplied by an external stimulator, as is shown in FIGS. 1 and 2. The external stimulator also being remotely controllable from a distant location via the internet. Controlling circuitry within the device, makes the inductively coupled stimulator and the IPG operate in harmony with each other, as described later. For example, when stimulation is applied via the implanted stimulus receiver 68, the battery operated pulse generation module 70 is triggered to go into the “sleep” mode. Conversely, when programming pulses (also inductively coupled) are being applied to the battery operated pulse generator, the inductively coupled stimulation circuitry is disconnected.
In the method and system of the current invention, after the system is implanted in the patient, optimal stimulation parameters are “titrated” for the condition of the individual patent. Clinical research has shown that each patient is biologically unique and responds little bit differently to given stimulation. The inductively coupled stimulation part of the system is a very convenient method of adjusting the parameters for stimulation therapy, that would be optimally suited for each individual patient. Further, as shown in FIG. 3, the external stimulator has a telemetry module and can be controlled remotely via the internet. In one embodiment, numerous pre-determined programs are pre-packaged into the memory of the external stimulator 42. A physician situated remotely is able to selectively activate (and de-activate) selected pre-packaged (pre-determined) programs. As shown in FIGS. 4 and 5, the telemetry module within the external stimulator wirelessly communicates with a base station 2, either via a server (shown in FIG. 4) or directly (shown in FIG. 5). Also, as shown in FIG. 6, a physician in a remote location is able to interrogate and selectively program the external stimulator 42 via a server 130.
Once the appropriate stimulation parameters are determined by “trial and error”, the battery operated portion of the implanted pulse generator can be programmed to the optimal electrical stimulation parameters via a programmer 85. For ideal therapy the electrical stimulation parameters need to be adjusted at regular intervals taking into account optimal benefits.
Another distinct advantage of the current system is that when the stimulation is performed via the external stimulator 42, the battery of the implanted pulse generator (IPG) 70 is conserved, extending the life of the implanted system.